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CTRI Number  CTRI/2022/03/041087 [Registered on: 15/03/2022] Trial Registered Prospectively
Last Modified On: 14/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   biological and radiological evaluation of osseointegration around implants with and without L-PRF. 
Scientific Title of Study   biological and radiological analysis of osseointegration around implants before and after biomimetic functionalisation with Leukocyte and Platelet Rich Fibrin 
Trial Acronym  LPRF 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nivya John 
Designation  Lecturer 
Affiliation  AB Shetty Memorial Institute of Dental Sciences 
Address  Department of Prosthodontics and Oral Implantology AB Shetty Memorial Institute of Dental Sciences Deralakatte
Nitte Deemed to be University Deralakatte
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9742024358  
Fax    
Email  nivyajohn@nitte.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Manoj shetty 
Designation  Professor and Head 
Affiliation  AB Shetty Memorial Institute of Dental Sciences 
Address  Department of Oral Implantology AB Shetty Memorial Institute of Dental Sciences Deralakatte
Nitte Deemed to be University Deralakatte
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845267087  
Fax  -  
Email  drmanojshetty@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Nivya John 
Designation  Lecturer 
Affiliation  AB Shetty Memorial Institute of Dental Sciences 
Address  Department of Prosthodontics and Oral Implantology AB Shetty Memorial Institute of Dental Sciences Deralakatte
Nitte Deemed to be University Deralakatte

KARNATAKA
575018
India 
Phone  9742024358  
Fax    
Email  nivyajohn@nitte.edu.in  
 
Source of Monetary or Material Support  
AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES,NITTE DEEMED TO BE UNIVERSITY 
 
Primary Sponsor  
Name  DR NIVYA JOHN 
Address  AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES 
Type of Sponsor  Other [SELF FUNDED] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nivya John  AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES  Department of Oral Implantology third floor,ab shetty memorial institute of dental sciences,deralakatte
Dakshina Kannada
KARNATAKA 		 9742024358

nivyajohn@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NITTE Central Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LPRF APPLICATION   Application of the PRF products: At the time of surgery. After the preparation of the osteotomy site, All the implants will be placed at a minimum insertion torque of 25 Ncm assessed by the physio-dispensor. L PRF will be removed from test tube, using sterile tweezers and will be inserted on the implant bed and implant will be coated with LPRF and then placed on edentulous side selected. The contralateral site will be placed with an implant with the similar design without the application of LPRF. DURATION :6-12MONTHS  
Comparator Agent  NIL  N/A 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion Criteria:
Patient requiring implant treatment bilaterally in the maxillary and mandibular arch(D3 ,D4 BONE)
Patients with bilateral edentulous with presence of a tooth on either side of edentulous space
Patients at least 20 years old, providing consent for documentation and public presentation of their clinical data.
Patients with fair Oral health Index
 
 
ExclusionCriteria 
Details  Patients with uncontrolled diabetes, recent cardiac surgery,patients on bisphophanates
Patients with bleeding disorders
serum glycated haemoglobin ≥ 7.0,
prescription of anti‐inflammatory medications, or antibiotics within the preceding 3 months,
Patient with poor oral hygiene index scores(<4) 
the use of medications known to have an impact on gingival growth.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improved Osseointegration in LPRF sites.  baseline: preoperative investigation
8 weeks: post op investigation
12 months : post cementation investigation 
 
Secondary Outcome  
Outcome  TimePoints 
clinical evaluation :BLEEDING ON PROBING ,SULCULAR DEPTH

BIOMARKER ANALYSIS:PRESENTATION OF INFALMMATORY MARKERS 		 3MONTHS POST IMPLANT PLACEMENT
12 MONTHS POST CEMENTATION 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/03/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response (Others) - 

  4. For what types of analyses will this data be available?
    Response (Others) - 

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 25-03-2022 and end date provided 04-06-2024?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Aim:

•To assess the effect of L-PRF on  implant stability,crestal bone levels and wound healing of implants in low density bone .


•Primary objectives
•To assess the effect of L-PRF on  osseointegration of implants in low density bone.
•To assess the biomarker expression from the samples (Periimplant Crevicular Fluid(Peri implant crevicular fluid) and Saliva) with and with LPRF Treatment
• To estimate the density changes using Cone-Beam Computed Tomography (CBCT) around  implants
•Secondary objectives:

1.To evaluate the effect of PRF on clinical parameters related to soft tissue healing, post-surgical pain/inflammation and early complications of mandibular implants in edentulous patients.

2. soft tissues volumetric changes pre and post- surgery using intraoral scans


Preoperative investigations and Preparation:

•A complete blood profiling ,Oral Hygiene Index ,Bleeding on Probing, Pre operative Orthopantomograph  will be done for each patient TO ESTABLISH  baseline parameters
•Prophylactic pharmacological management will also be done AT THE SURGICAL PHASE.
•Implant selection as per the bone architecture WILL BE DONE 
•Sampling Method: Convenient sampling
• Patients will be recruited from the OPD at the Department of Oral Implantology at AB SHETTY MEMORIAL INSITITUTE OF DENTAL SCIENCES,NITTE DEEMED TO BE UNIVERSITY.,MANGALORE
•Based on the observations from previous literature ,the following sample size estimation is done.1
•η=(z/2  + zβ) σ2
•(μ-μ0)2
• 
•n=(1.96+0.84)2  *(15.22)2/(17.81-7.82)2
• 
•18.16 samples per group
•Considering loss to follow up of 10%, 20 samples per group
•Study group(LPRF Rx)=20 samples
•Control group= 2o sample
•Each patient will have one edentulous area on each quadrant of the U/L  Jaw.


Implant installation & Site  Randomisation :

•At the time of surgery, randomization codes (+ for  intervention) will be generated using the randomization software (sealed envelopeTM). The site will be selected as per slot.The side with (plus) code will receive LPRF application .
•Only one of the site per patient  will be selected for the intervention.

Surgical phase:

• Each patient will be administered 1 gram of amoxicillin before surgery. Local anaesthesia will be achieved bilaterally by infiltrating lignocaine 2% containing 1:80000 adrenaline.
•The implant site preparation will be performed in a similar manner for the two edentulous sites. A full thickness flap reflection, osteotomy site will be prepared as per manufacturers instructions, implants (Straumann, Bone Level , or Tissue level,Basel, Switzerland) will be placed bilaterally depending on the case selection

Liquid Platelet Concentrate and Exudate Preparation:

•10cc of blood will be will be collected to obtain the L-PRF. The centrifuge (Duo Quattro) is equipped with pre programmed operational panel for the centrifugation of blood.
•Thus L PRF (2300 rpm for 12mins) will be obtained as per manufacturers recommendations .

Application of the PRF products:

•After the preparation of the osteotomy site, All the implants will be placed at a minimum insertion torque of 25 Ncm assessed by the physio-dispensor.
•L PRF  will be  removed from test tube, using sterile tweezers and will be inserted on the implant bed  and implant will be coated with LPRF and then placed on edentulous side selected. The contralateral site will be placed with an implant with the similar design without the application of LPRF.

Post operative evaluation and follow up:

•An immediate post operative OPG will be recorded .
•The patient will on therapeutic dose of antibiotics and analgesic until the day of suture removal.
• Patient will be advised to use local antibacterial mouthwashes.

Biomarker study at 0,6,12 months

Procedure:

•The gingiva will be dried by air and cotton pellets for 1 min before sampling and the area will be isolated using cotton rolls.A paper strip of standard length and height (Periopaper, Pro Flow, Amityville, NY, USA) will be inserted into the peri-implant sulcus will be left in place for 30 seconds. Strips macroscopically contaminated with blood or saliva will be discarded. The sample strip will be inserted into plastic sealable Eppendorf tubes and eluated in 100 microlitre of sterile NaCl.
•Following 10 s of vortexing, eluates will be centrifuged and the strips will be removed. The samples will be stored at -80 degree C.
•Enzyme-linked immunosorbent assay (ELISA) for Proinflammatory cytokine (IL-1b and TNF-a) and chemokine (IL-8 and MIP1a) concentrations in Peri implant crevicular fluid eluates will be assessed using commercially available ELISA kits (R&D, SAD)
•Quantokine Immunoasay for Human IL-1 beta (cat. number DLB50), Human TNF-alpha (cat. number DTA50), Human IL-8 (cat. number D800C), Human MIP-1 alpha (cat. number DMA00).
• MMP8 MARKER will be evaluated for evalauation of  bone turnover rate.

Osseointegration Speed Index:

•The Implant Stability Quotient values will be measured at the time of implant placement (to check the stability of the implants)
•3 months and 6 month post operatively (Ostell ISQ)
•
•Radiological assessment:
•The quantity of initial bone present will be measured in OPG
•A Cone Beam Computed Tomography (CBCT) will be taken  6 months and 12 months after implant placement.
•The measuring tool in the software will be used to measure the crestal bone levels.
• Also the Hounsfield units will be measured adjacent to the first two and last two implant threads. (density levels)The Planmeca Romexis® software version 3.1 will be used to evaluate the CBCT scan
1.The normality of the data will be assessed using Kolmogorov Smirnov’s Test and Shapiro Wilk’s Test.
2.Continuous variables will be measured in terms of mean and standard deviation for normally distributed data and median and Interquartile Range for non-normally distributed data.
3.Chi squared test will be used to assess discreate variables and will be expressed in terms
4.For normally distributed data, unpaired t test will be used and for non-normally distributed data Mann-Whitney U test will be used.
5.Repeated measured ANOVA will be used to determine the biomarker expression at different time intervals.
6.P value less than 0.05 will be fixed to determine the statistically significant difference.
7.Statistical Analysis will be done using SPSS Software (SPSS Version 22, IBM,Chicago, IL, USA) 
•
 
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